(312 days)
The device is an infrared thermometer intended for the intermittent measurement of human body temperature in people of all ages.
AVITA Infrared Thermometer with Bluetooth Model no.: TS28B
This document is a 510(k) cleared device, meaning it is substantially equivalent to a predicate device. As such, it is not required to provide a study that proves the device meets the acceptance criteria but rather a study to demonstrate its equivalence.
Here's the breakdown of the information that can be extracted from the provided text regarding the AViTA Infrared Thermometer with Bluetooth Model no.: TS28B:
1. A table of acceptance criteria and the reported device performance
The provided text from the FDA 510(k) clearance letter does not include specific acceptance criteria or detailed reported device performance (e.g., accuracy, precision values). The letter states that the device has been determined to be "substantially equivalent" to legally marketed predicate devices. For a 510(k) submission, the manufacturer would have submitted testing data demonstrating that their device performs as intended and is as safe and effective as the predicate device. However, these specific test results and acceptance criteria are not typically included in the public FDA clearance letter.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not available in the provided document. A 510(k) clearance letter does not usually contain details about the sample size or data provenance for the underlying studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not available in the provided document. Given that this is a medical device for measuring body temperature, the "ground truth" would likely be established using a highly accurate reference thermometer, not expert interpretation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not available in the provided document. Adjudication methods are more relevant for subjective evaluations, such as image interpretation. For a thermometer, the measurement is objective.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
A multi-reader multi-case (MRMC) comparative effectiveness study is not applicable here. This type of study is relevant for diagnostic devices that involve human interpretation, often assisted by AI. This device is a thermometer for direct measurement, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
The device is an infrared thermometer. Its performance is inherently "standalone" in that it directly measures temperature. It does not employ an algorithm that requires human-in-the-loop performance in the way AI-driven diagnostic tools do. The performance evaluation would focus on its accuracy and precision against a reference standard. Specific details of such a test are not provided in this document.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For a clinical electronic thermometer, the ground truth would typically be established by comparison to a highly accurate reference thermometer (e.g., a calibrated clinical mercury thermometer or a highly precise electronic thermometer that serves as a standard). This information is not explicitly stated in the provided document.
8. The sample size for the training set
This information is not applicable in the context of this device as described. Infrared thermometers are not typically "trained" using a dataset in the way a machine learning algorithm is. Their performance is based on their physical sensing capabilities and calibration.
9. How the ground truth for the training set was established
This information is not applicable for the reasons stated in point 8.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JAN - 6 2012
AViTA Corporation C/O Ms. Jennifer Reich Senior Consultant Harvest Consulting Corporation (USA) 2904 N. Boldt Drive Flagstaff, Arizona 86001
Re: K110559
Trade/Device Name: AViTA Infrared Thermometer with Bluetooth Model no .: TS28B Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: January 4, 2012 Received: January 5, 2012
Dear Ms. Reich:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include - -requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Reich
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing ( 1 CFR Partice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Anthony D. Amato
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): צענט 559
Device Name: AVITA Infrared Thermometer with Bluetooth Model no.: TS28B
AVITA Corporation
Indications for Use:
The device is an infrared thermometer intended for the intermittent measurement of human body temperature in people of all ages.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
V Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
the for RZC
(Division Sign-Off) Division of Anesthesiology, General Hospital infection Control, Dental Devices
10(k) Number: K110559 Page 1 of 1
§ 880.2910 Clinical electronic thermometer.
(a)
Identification. A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:(1) Device is not a clinical thermometer with telethermographic functions;
(2) Device is not a clinical thermometer with continuous temperature measurement functions; and
(3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.